Effect of Adding Renin-Angiotensin System Inhibitors to Standard Antidiabetic Therapy on Glycemic Control in Patients With Type 2 Diabetes Ellitus
NCT04707508 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 203
Last updated 2021-01-13
Summary
Type 2 diabetes mellitus (T2DM) is a progressive metabolic disorder in which a substantial number of patients cannot attain treatment target despite antidiabetic drugs. The renin-angiotensin system (RAS) has recently been implicated in the development of insulin resistance and impaired glucose metabolism. This study investigates the effect of adding RAS inhibitors to standard antidiabetic therapy in patients with T2DM. The primary outcome measure is the change in serum glycosylated hemoglobin A1c after 24 weeks of treatment. Secondary outcomes measures include changes in plasma lipid profile and blood pressure after treatment.
Conditions
- Diabetes Mellitus, Type 2
Interventions
- DRUG
-
Valsartan 80 mg and metformin
Valsartan 80 mg once daily in addition to metformin monotherapy
- DRUG
-
Metformin monotherapy
Sponsors & Collaborators
-
Nantou Christian Hospital
lead OTHER
Principal Investigators
-
Po-Chung Cheng, MD · Nantou Christian Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-12-01
- Primary Completion
- 2019-01-23
- Completion
- 2019-11-29
Countries
- Taiwan
Study Locations
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